Mako Surgical Corporation recalls MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
- Recall date
- December 22, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1411-2017
- FDA classification
- Class II
- Brand / firm
- Mako Surgical Corporation
- Sold / distributed
- US nationwide distribution.
Why it was recalled
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
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